Immunogenicity and Safety of a Cell-derived Influenza Vaccine in Elderly
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
A controlled, double-blind study to determine the immunogenicity and safety of influenza cell derived vaccine in elderly subjects.
Full description
This current phase II study is to pursue objectives similar to those of the ongoing adult phase II trial, but to expand into the elderly population who are more than 60 years of age. The results of this randomized, double blind, egg derived influenza vaccine (Influvac) - controlled, parallel-trial, in healthy elderly subjects are to be conducted over two consecutive years in multiple centers in Europe. At study initiation 600 subjects will be randomly allocated to receive the cell-derived or egg-derived influenza vaccine. At start of the second year subjects will be randomly re-allocated following stratification based upon the initial drug they were allocated and had received.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
- Willing and able to give informed consent and able to adhere to all protocol required study procedures.
- Men and women (elderly)
- Being in good health as judged by medical history, physical examination and clinical judgment of the investigator.
Exclusion Criteria
- Known to be allergic to constituents of the vaccine.
- A serious adverse reaction after a previous (influenza) vaccination. Presence of any significant condition that may prohibit inclusion as determined by the investigator.
- Having received vaccination against influenza or lab confirmed influenza within the previous six months before study vaccination.
Trial design
Primary purpose
Allocation
Interventional model
Masking
622 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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